Director, CMC Project Management

We are seeking a Director of CMC Project Management who will have responsibility for delivering operational success across the entire Scorpion development portfolio. This role will lead the integrated project management for chemical development (drug substance), formulation development (drug product), analytical development (drug substance and drug product) and packaging & labeling (finished product). The role will operate within a 100% outsourced business model, the incumbent will be accountable for team strategy and deliverables, ensuring operational excellence with respect to timelines, budgets, and attainment of technical, regulatory, and business goals/milestones. This person will also be leveraged as a thought partner for the CMC function that works with associated departments to ensure all key stakeholders are aligned with the overall CMC strategy to support the programs.

The ideal candidate will effectively balance the need for organization and adherence to timelines with the adaptability required in a fast-paced, growing company. S/he will have a demonstrated record of ensuring successful project outcomes by building strong cross-functional relationships, ensuring clear communication, and efficiently managing team resources to achieve a common goal.

KEY RESPONSIBILITIES

• Develop and maintain fully integrated CMC project plans, incorporating activities, internal/external resource requirements and key interdependencies, that deliver tangible results against program and corporate goals
• Establish and implement operational mechanisms to facilitate effective and timely cross-functional communication and decision making, and successful execution of program plans
• Provide team and meeting management, including meeting agenda, action plans and thorough follow-up
• Support development and implementation of PM systems and best practices to ensure consistency and operational effectiveness within and across functions and programs
• Financial accountability for all CMC programs ensuring budgets are created, executed to, and change controls are managed appropriately
• Identify, define, prioritize, and communicate risks to successful program execution; develop and monitor risk mitigation and contingency plans.
• Direct and coordinate multiple projects to ensure on-time and in-budget completion
• Organize and plan project tasks and schedules utilizing industry-standard tools such as Smartsheets, MS-Project
• Manage tasks in accordance with Project Management Institute (PMI) standards and those of the company
• Communicate project status to stakeholders and key project participants
• Ensure CMC goals and strategies align with business priorities
• Facilitate and encourage collaboration across functions to ensure projects are completed successfully
• Manage and facilitate internal and external CMC meetings, activities include, meeting minutes, agenda, setting up critical meetings as needed and action items
• Participate in Development Project Team meetings as needed, support the leadership team, and align strategy with key stake holders
• Create presentations, dashboards, and reports to communicate project status, key internal metrics, or risk mitigations
• Keep the project team focused on the end goal

PROFESSIONAL EXPERIENCE/QUALIFICATIONS

• A minimum of 7 years of R&D and/or drug development project management or cross-functional team leadership experience in the pharmaceutical industry
• Bachelor degree in a physical science, life science or engineering
• Preference for project management certification by a recognized project management organization (e.g. PMI, IPMA)
• Direct experience of interactions with CDMOs and manufacturing operations
• Proven success working in cross-functional teams
• Strong scientific background and knowledge of the drug development process
• Skill in fostering open communication, mutual understanding, and cooperation
• Strong understanding of productivity tools Microsoft Project/Smartsheet, Power Point, Excel, Word along with other related software
• Experience in managing multiple programs at one time, can work well with different management styles to keep a project moving
• Track record of success in managing cross-functional projects and supporting team decisions
• Competency in developing, implementing, and delivering CMC project plans (milestones, timelines, resources, etc.) to successful endpoints
• Self-directed, accomplishment-driven individual with a strong sense of passion and urgency who can work both independently and in a cross- functional team environment
• Experience in developing and commercializing drugs for oncology is an advantage